(90 days)
APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.
The subject device includes various designs for internal fixation of the distal tibia and distal fibula; additional lengths of 3.5 TriLock Screws (locking screws, other lengths cleared in K110908); a new design of 3.5 Cortical Screws (non-locking) in various lengths; and a new design of concave washer for use with Medartis 3.5 Cortical Screws. The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The plat designs include: 3.5 TriLock Distal Tibia L Plates and T Plates; 2.8/3.5 TriLock Distal Tibia Plates Medial; 2.8/3.5 TriLock Distal Tibia Plates Anterolateral; 2.8/3.5 TriLock Distal Fibula Plates Lateral, with and without Flap; 2.8 TriLock Distal Fibula Plates Crossed; and 2.8 TriLock Distal Fibula Plates Straight. The subject device plates are used with TriLock locking screws and non-locking screws (cortical and cancellous), including subject device screws and previously cleared Medartis screws. Compatible TriLock locking screws and non-locking cortical screws have a diameter of 2.8 mm and 3.5 mm, and overall lengths ranging from 8 mm to 60 mm. The 2.8 Cortical Screws (non-locking) and 3.5 Cortical Screws (non-locking) have a double-lead thread design. All TriLock Screws (locking) have a double-lead thread design. The subject device plates also are compatible with Medartis K-Wires cleared in K092038. The subject device screws include screws with the same design as 3.5 TriLock Screws cleared in K110908, with a diameter of 3.5 mm and provided in additional lengths of 10 mm, 12 mm, and 14 mm. The subject device screws also include a new design of 3.5 Cortical Screws provided with a diameter of 3.5 mm and lengths of 10 mm to 60 mm. The subject device plates, washer, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. The subject device components are provided non-sterile to the end user.
The provided document is a 510(k) summary for the Medartis AG APTUS® Ankle Trauma System 2.8/3.5. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It focuses on the non-clinical performance data (biocompatibility, sterilization, engineering analysis, and mechanical testing) to demonstrate equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons of technological characteristics. The "reported device performance" is essentially that it met the requirements of these non-clinical tests and is comparable to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Referenced from previously cleared devices (K091479, K103332, K192297, and K191848). Implied to meet established biocompatibility standards. |
| Sterilization (for non-sterile components) | To be sterilized by moist heat (by the end-user), referenced from previously cleared devices (K091479, K103332, K192297, and K191848). Implied to meet sterilization efficacy. |
| Sterilization (for sterile components) | X-ray beam sterilization, referenced from K191848. Implied to meet sterilization efficacy. |
| Packaging and Sterile Barrier Shelf Life | Referenced from K191848. Implied to meet standards for maintaining sterility over time. |
| Engineering Analysis (Structural Integrity/Design Validation) | Performed. Details not provided, but implies the design is sound and comparable to predicate devices. |
| Mechanical Testing (e.g., strength, fatigue) | Performed according to ASTM F382 (Standard Specification for Metallic Bone Plates) and ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws). The document explicitly states the primary predicate device K013248 "is in support of substantial equivalence in terms of comparison mechanical testing" and additional predicate devices are for "comparative mechanical testing." |
| Material Composition | Plates: Unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. Screws: Ti-6Al-4V alloy, ASTM F136. Washer: Titanium alloy conforming to ASTM F136. This aligns with predicate and reference devices. |
| Indications for Use | Demonstrated as substantially equivalent to predicate devices, noting minor differences that do not impact substantial equivalence. |
| Technological Characteristics (Design, Components, Manufacturing) | Demonstrated as substantially equivalent to predicate devices, noting similar designs, compatible components, and identical manufacturing processes and materials for Medartis AG devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "Clinical data were not provided in this submission." This means there was no human-patient-based test set. All data presented (biocompatibility, sterilization, mechanical testing, engineering analysis) are non-clinical.
- Sample Size for Test Set: Not applicable, as no clinical test set was used.
- Data Provenance: Non-clinical (laboratory/bench testing, engineering analysis). No country of origin for human data as none was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a metallic bone fixation system, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance evaluation is based on established engineering and materials standards (e.g., ASTM F382, ASTM F543, ASTM F67, ASTM F136), and documented performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable, as no machine learning algorithm requiring a training set was used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no machine learning algorithm requiring a training set was used.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.